FDA Law Blog

DECEMBER 4, 2023

The government asserted additional allegations that are outside our scope. Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” Zarzamora Press Release. Complaint ¶ 55.

Treatment Plan 139

Treatment Plan ER Government Patient-Centered 139

FDA Law Blog

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. By David B. Clissold & Sara W.

Manufacturing 115

Manufacturing IT Provider ER 115

FDA Law Blog

SEPTEMBER 6, 2021

Teva case, that the statutory provisions governing patent infringement, specifically induced infringement, do not address carve-outs. Instead, it was GSK who erred in omitting the post-MI language from the use code. The catch is, as we have learned from the GSK v.

IT 52

IT Provider ER Insurance 52

GeriPal

APRIL 18, 2024

I remember walking through San Francisco Airport with Bob, we just happened to be there at similar times, and saying, “Eric and I are thinking about starting a blog.” I think a lot of back office function, predicting ER loads and OR loads to do better scheduling of staff. I think we’re smarter about it than we were.

IT 139

IT Electronics Patients Healthcare 139